Journal Article

Results of the CAPSID randomized trial for high-dose convalescent plasma in patients with severe COVID-19

Corman, Victor M., Rosenberger, Peter, Seifried, Erhard, Appl, Thomas, Kalbhenn, Johannes, Thiele, Thomas, Grüner, Beate, Schmidt, Michael, Zinn, Sebastian, Schrezenmeier, Hubert, Ernst, Lucas, Zacharowski, Kai, Kirschning, Thomas, Jungwirth, Bettina, Paul, Gregor, Dollinger, Matthias M., Körper, Sixten, Weiss, Manfred, Wiesmann, Thomas, Drosten, Christian, Lepper, Philipp M., Spieth, Peter, Zickler, Daniel, Kruse, Jan Matthias, Bentz, Martin, Mayer, Benjamin, Wulf, Hinnerk

2021

Overview

BACKGROUNDCOVID-19 convalescent plasma (CCP) has been considered a treatment option for COVID-19. This trial assessed the efficacy of a neutralizing antibody containing high-dose CCP in hospitalized adults with COVID-19 requiring respiratory support or intensive care treatment.METHODSPatients (n = 105) were randomized 1:1 to either receive standard treatment and 3 units of CCP or standard treatment alone. Control group patients with progress on day 14 could cross over to the CCP group. The primary outcome was a dichotomous composite outcome of survival and no longer fulfilling criteria for severe COVID-19 on day 21.ResultsThe primary outcome occurred in 43.4% of patients in the CCP group and 32.7% in the control group (P = 0.32). The median time to clinical improvement was 26 days in the CCP group and 66 days in the control group (P = 0.27). The median time to discharge from the hospital was 31 days in the CCP group and 51 days in the control group (P = 0.24). In the subgroup that received a higher cumulative amount of neutralizing antibodies, the primary outcome occurred in 56.0% of the patients (vs. 32.1%), with significantly shorter intervals to clinical improvement (20 vs. 66 days, P < 0.05) and to hospital discharge (21 vs. 51 days, P = 0.03) and better survival (day-60 probability of survival 91.6% vs. 68.1%, P = 0.02) in comparison with the control group.ConclusionCCP added to standard treatment was not associated with a significant improvement in the primary and secondary outcomes. A predefined subgroup analysis showed a significant benefit of CCP among patients who received a larger amount of neutralizing antibodies.Trial registrationClinicalTrials.gov NCT04433910.FundingBundesministerium für Gesundheit (German Federal Ministry of Health): ZMVI1-2520COR802.

• Publisher: American Society for Clinical Investigation
• Subject: Aged / Antibodies / Antibodies, Neutralizing - administration & dosage / Antibodies, Neutralizing - therapeutic use / Antibodies, Viral - administration & dosage / Antibodies, Viral - therapeutic use / Biomedical research / Care and treatment / Clinical Medicine / Clinical outcomes / Clinical trials / Combined Modality Therapy / Coronaviruses / COVID-19 / COVID-19 - immunology / COVID-19 - physiopathology / COVID-19 - therapy / Cross-Over Studies / Demographics / Female / Hospital patients / Humans / Immunization, Passive - adverse effects / Immunization, Passive - methods / Inflammation / Intensive care / Kaplan-Meier Estimate / Male / Middle Aged / Mortality / Pandemics / Patients / Plasma / Prospective Studies / SARS-CoV-2 - immunology / Severe acute respiratory syndrome coronavirus 2 / Severity of Illness Index / Survival / Treatment Outcome / Ventilators